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The quality management system documents include the following eight categories: quality manuals, procedure documents, work books, product quality standards, testing technical specifications and standard methods, quality plans, quality records, and test reports.
The quality system documents are generally divided into three or four levels, and the laboratory can be specified according to its own monitoring needs and habits.
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What documents are included in the QMS document? For this problem, the majority of construction people may not be very clear, the following is the construction network to bring about the quality management system documents including the content of the content of the document for reference.
It can be divided according to the needs of its own organization, and is generally divided into two categories: system documents and external documents. Give you the classification of documents from my unit for reference.
File categorization. Administrative Documents:
a) Quality manual (including documented quality policy and quality objectives);
b) program documentation;
c) Departmental work instructions;
d) Other management documents (such as various management systems, job responsibilities, management review reports, internal audit reports and related supporting documents);
e) Records**.
Technical Documents:
a) process documentation;
b) Applicable international, national and industry standards;
c) Service specifications, service provision specifications, quality control specifications, technical standards, inspection specifications, quality plans, management regulations, etc. prepared by the group or department.
External documents: a) Laws, regulations, standards, superior documents from outside the group;
b) Drawings, technical data, contracts, agreements, business documents, safety or quality assurance documents provided by customers or suppliers, etc.
Controlled and non-controlled files.
Documents can be divided into two categories: "controlled" and "uncontrolled":
a) a "controlled" document is a document that is under the control of the Group and in which changes can be implemented, which is a change notification version, which can be traced back to all users when changes are made, and changes are implemented to ensure that it is current;
b) "Uncontrolled" documents refer to external documents, group system documents that do not require change control (including documents for bidding, off-site use by customers and other special issuances, production plans, monthly quality reports, season-related operation documents and other documents that are automatically invalidated when they expire with timeliness).
Controlled documents shall be stamped with a "controlled" seal and shall be registered for distribution and marked with a distribution number. Non-controlled documents are issued after approval by authorized personnel, and are only for issuance registration, without a distribution number. When the group's controlled documents are issued as non-controlled documents (e.g. bidding, off-site use by customers), they should be stamped with the "uncontrolled" seal.
The form of the file.
Documents can be in any form or type of medium, such as paper, hard copy, electronic**, etc.
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Quality system documentsThe principles of writing include:
1. The quality system document should be systematic and coordinated.
The quality system document should be able to reflect the systemic characteristics of an organization's quality system and respond to the impact on the quality of the product or service.
The control of technical, managerial and personnel factors in the formation process is uniformly regulated. Different documents should be clearly hierarchical, clearly interfaced, reasonably structured, coordinated and reordered, and appropriately selected elements and contents in terms of various levels and document quality.
2. The preparation of quality system documents should meet the requirements of regulations.
A quality system document is an organization that implements quality management.
and guidelines for quality assurance activities.
3. The quality system document should have a high crude value of increased sales.
4. The preparation and application of quality system documents is a process, and the process of loss is a dynamic and high value-added conversion process.
5. The quality system documents should meet the requirements of suitability.
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1. The preparation of quality system documents should design the quality management system from the organizational level, including quality planning, quality assurance, quality control, quality assessment, etc. 2. The quality system document should be prepared with the company's quality policy, quality management organizational structure, quality responsibilities, quality plan, quality assurance, quality control, quality inspection and defect handling. 3. When compiling quality system documents, the requirements are simple and clear, practical, and operable, so that the quality management system is more implementable and implementable.
4. The preparation of quality system documents should be based on the actual situation of the company, combined with the company's quality policy, customer requirements and industry norms, etc., to ensure the scientificity, rationality and operability of the documents.
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All levels of quality management system documents, should be planned and prepared according to the standard requirements, industry characteristics and the actual situation of the supervision unit, the prepared documents should be advanced in a certain period of time, suitability and operability. The main points of the preparation of the documents are:
1) Quality Manual.
The quality manual should be written in accordance with the principle of "what is to be done, what is written". According to the requirements of the standard, the content of the quality manual should be prepared: quality manual description, management commitment, documented system requirements, management responsibilities, resource management, product realization and measurement analysis, improvement, etc.
2) Program files.
The content and quantity of the program documents shall be determined by the supervision unit according to the management requirements. According to the requirements of the standard, the six basic procedure documents that the supervision unit must prepare are: document control, quality record control, nonconforming product control, internal audit control, corrective action control and preventive measures control.
Based on the particularity of the supervision products, from the perspective of meeting the needs of the supervision work and improving the quality management level, the supervision unit can also prepare human resources control, inspection and measurement control and owner satisfaction monitoring measurement control and other program documents.
3) Work instructions.
The guidance is a technical document to guide the supervision work, which should be prepared in accordance with the laws and regulations, norms and standards of the national and industry engineering supervision and the quality manual "product realization" chapter on the planning and control of supervision services. The content of the work instruction should be based on the planning and control content of the supervision service, and then further refined, supplemented and connected.
4) Record the sale and transportation of goods**.
The quality record is an objective reflection of the degree to which the product meets the quality requirements and the results of various quality activities in the quality management system of the supervision unit. In the process of preparing program documents, the supervision unit should also prepare various quality records required for the implementation of the quality management system. Includes:
The first is records related to the quality management system, such as contract review records, internal audit records, management review records, training records, document control records, etc. The other type is the quality records related to the "products" of the supervision service, such as the records of the side station of the supervision of the middle destruction, the acceptance records of materials and equipment, the records of corrective and preventive measures, and the records of nonconforming products.
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1) Systematic.
The company should systematically and methodically formulate various policies and procedures for all elements, requirements and regulations adopted in its quality system;
All documents shall be compiled in the prescribed manner;
Documents at all levels should be reasonably distributed;
2) Coordination.
All provisions of the system document should be harmonized with other management regulations of the company;
The system documents should coordinate and corroborate each other;
The system documents should be coordinated with the relevant technical standards and specifications;
All kinds of interfaces should be carefully handled to avoid not radicalizing coordination or unclear responsibilities.
3) Sex for an organization, its quality system documentation is yes;
understanding achieved through clear, accurate, comprehensive, simple and concise expressions;
It is never permissible to use different and contradictory documents on the same subject matter at the same time;
Documents that are organized in different organizations can have different styles.
4) Applicability.
Prepare all kinds of documents according to the principle of "the simplest and most understandable";
All document preambles should be fully implemented in practice;
It is absurd to pursue a document that "applies at any time and in any sector", and it is not only possible to lead the number;
Any document should be prepared in accordance with the requirements of the standard and the reality of the enterprise;
If the unsuitability of the document is found, it should be immediately revised in accordance with the prescribed procedures.
GB T 19001-2008 is based on ISO9001:2008 translation.
You see that the standard cover of GB T 19001-2008 is marked in parentheses: ISO9001:2008, IDT >>>More
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